Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-06 @ 6:00 AM
Study NCT ID:
NCT06511856
Status:
RECRUITING
Last Update Posted:
2024-07-22
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FH ORTHO Shoulder Observatory
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2035-09-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-15', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of the medical devices over long term follow-up (maximum10 years)', 'timeFrame': 'maximum 10 years', 'description': 'Functional performance measured by the Constant-Murley score'}], 'secondaryOutcomes': [{'measure': 'revision rate medical devices over long term follow-up (maximum10 years)', 'timeFrame': 'maximum 10 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Trauma', 'Arthropathy Shoulder']}, 'descriptionModule': {'briefSummary': 'This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone shoulder joint replacement or repair following shoulder trauma.\n\nIn this type of intervention, one or more medical devices distributed by FH ORTHO SAS may be used by surgeons.\n\nThis study meets the requirement for post-market clinical follow-up (PMCF) as defined in the European Medical Device Regulation (MDR 2017/745).\n\nIt therefore involves collecting in real life, i.e. under the usual conditions of surgery and short and long-term patient follow-up, minimal clinical data that will make it possible to document the continued benefit/risk of the medical devices concerned.\n\nThis study is designed as a permanent long-term observatory, of a non-interventional nature, with the objective of having long-term follow-up data (5 to 10 years depending on the devices concerned) for a maximum number of patients included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient considered for implantation or use of medical devices for shoulder arthroplasty and traumatology distributed by FH ORTHO SAS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Any patient undergoing implantation of medical devices distributed by FH ORTHO SAS for shoulder arthroplasty and traumatology, used in accordance with their approved labelling, in one of the centres participating in the Observatory (retrospectively or prospectively)\n2. Patient is at least 18 years of age\n3. Patient agreeing to participate after having been informed orally and in writing (with written consent if required locally) In some countries, such as France, the patient will have to be socially insured to be included in the study.\n\nExclusion criteria:\n\n1\\. Patient unable to participate in the study and/or complete the questionnaires 2. Refusal of patient participation\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06511856', 'briefTitle': 'FH ORTHO Shoulder Observatory', 'organization': {'class': 'INDUSTRY', 'fullName': 'FH ORTHO'}, 'officialTitle': 'Observational Study of Shoulder Surgery Using FH ORTHO Medical Devices', 'orgStudyIdInfo': {'id': '2020-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FH ORTHO shoulder patients', 'description': 'Patients operated with FH ORTHO shoulder medical devices (arthroplasty and trauma)', 'interventionNames': ['Device: ARROW']}], 'interventions': [{'name': 'ARROW', 'type': 'DEVICE', 'otherNames': ['ARROW II', 'Telegraph Evolution', 'STRAPFLEX'], 'description': 'Patients included in the study are patients operated with one or more shoulder medical device fabricated by FH ORTHO. Medical devices of interest are CE marked and include ARROW and ARROW prosthesis, Telegraph Evolution humeral nail and STRAPFLEX strapping system.', 'armGroupLabels': ['FH ORTHO shoulder patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34400', 'city': 'Lunel', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Omar NAJI, Dr', 'role': 'CONTACT', 'phone': '+33 (0) 4 67 91 18 05'}], 'facility': 'Clinique VIA DOMITIA', 'geoPoint': {'lat': 43.67778, 'lon': 4.13611}}, {'zip': '75116', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe VALENTI, Dr', 'role': 'CONTACT', 'phone': '+33 (0) 184 130 454'}], 'facility': 'Clinique Bizet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31243', 'city': 'Saint-Jean', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean KANY, Dr', 'role': 'CONTACT', 'phone': '+33 (0)5.61.37.87.47'}], 'facility': "Clinique de l'Union", 'geoPoint': {'lat': 43.66519, 'lon': 1.50459}}], 'centralContacts': [{'name': 'Cédric FERRY', 'role': 'CONTACT', 'email': 'c.ferry@fhortho.com', 'phone': '+33 (0)6 49 63 78 29'}, {'name': 'Stéphanie LHUILLIER', 'role': 'CONTACT', 'email': 's.lhuillier@fhortho.com', 'phone': '+33 (0)6 07 34 59 65'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FH ORTHO', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}